Low enrollment

The aim of this study was to assess the therapeutic efficacy of secukinumab on the psoriatic skin and to explore the anti-inflammatory (reduction of hepatic inflammation and cell damage), anti-steatotic (reduction of hepatic triglyceride content) and anti-fibrotic (reduction of hepatic fibrosis) effects of secukinumab in patients with psoriasis and coexisting non-alcoholic fatty liver disease (NAFLD).

Primary outcome measure is Percentage of participants achieving ≥ 90% improvement (reduction) in PASI score compared to Baseline. Psoriasis Area and Severity Index (PASI) 90 response is defined as ≥ 90% improvement (reduction) in score compared to Baseline. It is a composite score where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. Score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. Primary analysis was planned to be performed comparing treatments with respect to the primary efficacy variable in a logistic regression model. It was planned to present the Odds Ratio and its 95%-confidence interval and p-value. Planned null hypothesis to be rejected was that the Odds Ratio of a PASI90 response for patients with secukinumab vs. patients with placebo is ≥1 after 12 weeks. Due to premature termination and limited number of treated patients with available data (7 in the secukinumab group and 3 in the placebo group), the extent of the originally planned statistical analyses of efficacy data was limited to descriptive summaries (absolute values per visit and changes from baseline; presented as mean and SD) for the score.

Inclusion Criteria:

• Male/female patients, 18 years or older
• Moderate to severe plaque-type psoriasis, candidate for systemic therapy
• Diagnosis of NAFLD by either ultrasound at Screening or liver histology within 6 months before Baseline
• BMI > 25 kg/ m 2
• ALT 1.2 to 3.0 × ULN
• MRI confirmed Liver fat ≥ 8% at Screening

Exclusion Criteria:

• Forms of psoriasis other than chronic plaque-type Psoriasis
• Drug induced psoriasis
• Pregnant or nursing (lactating) women
• Women of child bearing potential unless they are using effective methods of contraception
• Ongoing use of prohibited treatments
• Previous treatment with biological drug targeting IL-17 or the IL-17 receptor
• Past medical history record of infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C prior to Screening
• Unstable weight over the last 6 months prior to Screening.
• Type I diabetes, or uncontrolled diabetes (Type I or Type II) defined as HbAlc ≥ 10% at screening.
• Evidence of hepatic decompensation or severe liver impairment or cirrhosis
• History of liver transplantation or planned liver transplant or biliary diversion.
• Presence or history of other liver disease
• Current, or history of, significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening
• Prior or planned bariatric surgery
• Inability or unwillingness to undergo MRI of the abdomen
• Past medical history record of infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C prior to Screening

Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

double-blind

The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.